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Senior Quality Engineer – Chemistry

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A rapidly growing Medical Device client in south Orange County is looking to identify and hire a Senior Quality Engineer – Chemistry on a direct hire basis.  The Sr. Quality Engineer will be responsible for setting up and managing the GLP and GMP for the production and quality control chemistry labs. In addition, this Engineer will develop, implement, and maintain policies and procedures to ensure compliance with Quality System Regulations (QSR’s) for medical devices.

 

The Senior Quality Engineer will be responsible for, but not limited to:

  • Developing and establishing documentation control and approval work flows to support manufacturing and testing for processes, test methods, test results, batch records, etc.
  • Establishing practices for test method development, validation & transfer, as well as creating practices, policies, and procedures for out-of-specification results and non-conformances.
  • Developing material control procedures and policies for material flow in and out of the labs.
  • Implementing software control systems for the laboratories and test data that are compliant with FDA regulations.
  • Reading, comprehending, and following documents outlining all procedures related to Chemistry.
  • Maintaining and updating the Chemistry Data System for the labs which are compliant to Quality System Regulations.
  • Establishing and maintaining document control practices for the labs including batch records, data systems, and material releases.
  • Reviewing test results and release material for use.
  • Establishing and maintaining material control practices for the lab.
  • Performing audits of laboratory practices to confirm operations to established processes.
  • Maintaining and updating test method development, validation, and transfer processes.
  • Establishing and maintaining the out-of-specification test result process for Chemistry.
  • Maintaining and updating the non-conformance handling process for Chemistry.
  • Controlling materials for use in Manufacturing, Chemistry, and non-conforming materials.
  • Leading the review board on out-of-specifications and non-conformances.
  • Training associates on compliant procedures and practices for Chemistry.
  • Supporting audits as necessary with information from the Chemistry Group.
  • Performing corrective actions and root cause analysis as required.
  • Initiating change requests and approving change requests.
  • Creating, reviewing, executing, and approving test method and process validation protocols and reports.
  • Creating, reviewing, executing, and approving material test plans and reports.
  • Maintaining compliance to the latest standards and compendial methods for chemistry lab.
  • Creating and performing ad hoc reports as required.
  • Supporting outside laboratory studies that are performed to ensure proper test material controls, protocol creation and approval, protocol execution, data control, and report creation and approval.
  • Working with Product Development, Manufacturing, and Quality Control departments to ensure product quality and regulatory compliance.

Requirements:

  • Minimum BA or BS in Chemistry, Biology, or Chemical Engineering or equivalent with at least 4 years relevant work experience.
  • Must have at least 5-10 years of relevant Quality Assurance or Chemistry experience.
  • Preferably prior background/experience in a Chemistry Lab in medical device environment.
  • Must be eligible to work in the US without sponsorship.
  • Proficient with Microsoft office tools.
  • Prior experience in chemistry labs in a regulated environment.
  • Prior experience in quality systems in the medical device industry.
  • Excellent computer skills with Microsoft Word and a Laboratory Information Management System.
  • Experience in Chemistry in an FDA or ISO environment.
  • Professional, responsible, energetic and accountable.
  • Excellent communication skills.
  • Intellectually curious and eager to learn.
  • Quality-oriented and possess a natural attention to details.